Analysis of 4063 complications of shoulder arthroplasty reported to the US Food and Drug Administration from 2012 to 2016

J Shoulder Elbow Surg. 2018 Nov;27(11):1978-1986. doi: 10.1016/j.jse.2018.03.025. Epub 2018 May 11.


Background: Most of the literature on shoulder arthroplasty failure comes from high-volume centers. These reports tend to exclude the experience of community orthopedic surgeons, who perform most of the shoulder joint replacements.

Methods: We analyzed the failure reports mandated by the US Food and Drug Administration for all hospitals. Each reported event from 2012 to 2016 was characterized by implant, failure mode, and year of surgery.

Results: For the 1673 anatomic arthroplasties, the most common failure modes were glenoid component failure (20.4%), rotator cuff/subscapularis tear (15.4%), pain/stiffness (12.9%), dislocation/instability (11.8%), infection (9%), and humeral component loosening (5.1%). For the 2390 reverse arthroplasties, the most common failure modes were dislocation/instability (32%), infection (13.8%), glenosphere-baseplate dissociation (12.2%), failed/loosened baseplate (10.4%), humeral component dissociation/tray fracture (5.5%), difficulty inserting the baseplate (4.8%), and difficulty inserting the glenosphere (4.2%). Although the percentage distribution among the different failure modes was relatively consistent over the years of this study, the percentage distribution of these failure modes differed substantially among different implant manufacturers.

Conclusions: The Food and Drug Administration database reveals modes of shoulder arthroplasty failure that are not emphasized in the published literature, such as rotator cuff tear, infection, and postoperative pain/stiffness for anatomic total shoulder arthroplasty and implant dissociation and baseplate failure for reverse shoulder arthroplasty. Knowledge of these failure modes may help inform surgical technique and implant design in ways that will lower the risk of implant failure in the future.

Keywords: FDA; MAUDE; Shoulder arthroplasty; complications; failure; revision.

MeSH terms

  • Arthroplasty, Replacement, Shoulder / adverse effects*
  • Humans
  • Joint Diseases / diagnosis
  • Joint Diseases / epidemiology*
  • Joint Diseases / surgery
  • Joint Prosthesis / adverse effects*
  • Postoperative Complications / epidemiology*
  • Prosthesis Failure / adverse effects*
  • Range of Motion, Articular
  • Reoperation / adverse effects
  • Retrospective Studies
  • Shoulder Joint / surgery*
  • Treatment Outcome
  • United States / epidemiology
  • United States Food and Drug Administration